BDD With UDCA Therapy After Laparoscopic Cholecystectomy
NCT ID: NCT03578055
Last Updated: 2018-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
172 participants
INTERVENTIONAL
2018-04-24
2019-12-31
Brief Summary
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Primary endpoint: peak level of postoperative AST (aspartate transaminase) and postoperative ALT (alanine tansaminase)
Secondary endpoint: postoperative GIQLI (Gastrointestinal Quality of Life index) score
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BDD with UDCA
Postoperative BDD with UDCA treatment
BDD with UDCA
Dosage: Udex 1 capsule, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery
Placebo
Placebo
Placebo
Dosage: 1 capsule of placebo, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery
Interventions
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BDD with UDCA
Dosage: Udex 1 capsule, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery
Placebo
Dosage: 1 capsule of placebo, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Under 19 years
* If you have intellectual ability to understand this study
* When performing cholecystectomy with other operations
* Total bilirubin levels\> 2 mg / dl
* If you are enrolled in another clinical trial
18 Years
ALL
No
Sponsors
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Ewha Womans University Mokdong Hospital
OTHER
Responsible Party
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Huisong Lee
Assistant Professor
Principal Investigators
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Huisong Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ewha Womans University Mokdong Hospital
Locations
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Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BULQ-LC trial
Identifier Type: -
Identifier Source: org_study_id
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